What Are Controlled Documents And How To Implement?

In my auditing experience, I’ve observed that the cornerstone of effective management is the concept of ‘controlled documents.’ In this article, I’ll explain the concept of controlled documents and try to explain why they are important for your business and how to implement one.

First of all, we need to take a moment to realise the fact that documents are very important for any business to demonstrate its competence, excellence and compliance.

Think of controlled documents as the your knowledge you acquired over years. This knowledge is an essential part of business strategy for continuous improvement and overall stakeholder satisfaction.

Understanding Controlled Documents

Controlled documents are at the heart of a robust quality management system. In my role, I’ve seen how these documents function as the guiding instructions, policies and records that ensure a company’s operations meet the highest standards and of course their targets.

Controlled documents are not static; they are dynamic entities that evolve with the company’s ever-changing context.

The Importance of Controlled Documents

In my experience, the significance of controlled documents in maintaining and enhancing quality cannot be overstated. These documents serve as a blueprint for quality consistency across all operations.

For example, your company’s process documentation ensures that every product or service meets the same standards, regardless of when or by whom it is implemented. This consistency is key to customer satisfaction and regulatory compliance.

Employees often rely on these documents for guidance on their day-to-day tasks and responsibilities. For instance, your work procedure documents such as SOP (standard operating procedure) or WI (work instruction) clearly outline the steps employees must follow, which streamlines their workflow and reduces errors.

Controlled documents also play a critical role in training new employees, providing them with a clear and detailed understanding of your operational standards and procedures.

An example of controlled documents

For product-related companies, there might be a procedure manual for product quality testing. This document is called a controlled document because it ensures the application of knowledge (product test) is consistent.

The document is regularly revised based on new quality benchmarks, ensuring that the team always tests products with the most current and effective procedures.

That’s the reason why ISO standards emphasize controlled documents to ensure they deliver consistent and relevant application of knowledge.

Does that make sense now? No? Let’s continue..

Controlled Documents and ISO Standards

Delving into ISO standards, companies often feel that they place significant emphasis on controlled documents. Why? Because these are not just any documents but are specifically crafted to ensure consistency in all aspects of an organisation’s operations.

Controlled documents not only help in standardising operations but also provide a clear, auditable trail of how decisions are made and processes are executed.

7 Steps To Implement Controlled Documents

Implementing controlled documents in any company is a process that requires careful planning, clear guidelines and consistent follow-through. Here’s how I have approached it in my professional experiences, which could serve as a useful guide:

1. Identify Documents to be Controlled

The first step is to determine which documents need to be controlled to achieve consistent results. This typically includes any document that is crucial for quality assurance, compliance, or operational effectiveness.

For example, in many organisations, management identifies the key documents, such as manuals, training documents, contract agreements, policies and standard operating procedures (SOPs) requiring control.

2. Define Document Control Procedures

Establish clear procedures for creating, reviewing, approving, distributing, updating, and archiving documents. This should include who is responsible for each stage.

For example, in SOP creation process, the initial draft is prepared by the process owner, reviewed by the quality team, and approved by the department head. This ensures all parties are involved and the proper knowledge with the required resources is implemented.

3. Use a Document Management System (DMS)

These days, online document storage services such as Microsoft SharePoint or Google Drive can be a game-changer for managing controlled documents.

These services help in tracking changes, maintaining version control and ensuring easy and proper access to the latest versions of documents.

4. Train Everyone (including external parties)

Ensure all employees, contractors and other parties fully understand the importance of controlled documents and know how to access and use them.

Regular training or meeting sessions can be helpful. You can conduct workshops over coffee to familiarize staff with the new documents and how to access those controlled documents. And what not to!

5. Ensure Accessibility

Make sure that controlled documents are easily accessible to only those who need them, while also ensuring security and confidentiality. With online tools such as Microsoft SharePoint, it’s a lot easier to manage the accessibility and security of documents and records.

6. Regular Review and Update

Like I said above, controlled documents must be living documents that evolve with the changes around them. Encourage feedback from everyone on the controlled documents. This can provide valuable insights into how the documents are used and areas where they can be improved.

Schedule regular reviews to ensure they remain relevant and accurate. Retrain everyone to ensure awareness.

7. Audit and Improve

Regular audits of the controlled documents to identify areas for improvement. I often see an annual internal audit of document control procedures to ensure they are relevant and comply with ISO standards. Make adjustments as necessary.

Remember, implementing controlled documents is not a one-off tick but an ongoing process that requires attention and dedication.

By following these steps, organisations can ensure that their documents are not only compliant with ISO 9001 but also effectively contribute to the quality and efficiency of their operations. Each stage is critical to ensuring the document remains current and effective.

Common Questions

Final Thoughts

As you can see, controlled documents are a fundamental component of any effective management system. My auditing experience has shown that with proper understanding and implementation, controlled documents can significantly improve any company’s operations, ensuring consistency, compliance and continuous improvement. It’s not just about adhering to ISO standards but in fact embedding quality into the DNA of an organization. Good luck!